From March 16, the prescription of trimetazidine-based drugs will be reserved for cardiologists. This decision was taken by the National Medicines Safety Agency (ANSM) “due to the neurological adverse effects observed in patients treated with trimetazidine and the persistence of off-label use”.
The benefit of the treatment should also be reassessed by cardiologists at least every year. In the meantime, the renewal can be carried out by any therapist, in particular by the general practitioner.
90% of prescriptions were made off-label
Since 2012, following a European reassessment On the basis of their benefit / risk ratio, the indications for trimetazidine-based medicinal products have been restricted to the symptomatic treatment of angina pectoris (chest pain due to coronary artery disease) in adults.
The ENT and ophthalmological indications were withdrawn but they continued to be prescribed (in 90% of cases) for these pathologies.
“On the other hand, off-label use has been identified in the treatment of primary arterial hypertension although this indication has not been validated” underlines the ANSM.
Trimetazidine on the poisonous substances list
In view of these results, it was decided that the vastareland its generics could only be prescribed by cardiologists. In addition, trimetazidine has been included in List I of poisonous substances, which means that drugs containing this molecule can only be dispensed for the duration of treatment mentioned on the prescription.
The ANSM reminds patients that these drugs can induce or worsen symptoms such as tremor, stiff posture, slow movements, unbalanced gait with a tendency to drag the feet, especially in the elderly. If you experience such symptoms, report it to your doctor, who may re-evaluate your treatment.
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